Analgesic Current Therapies for Chronic Neck Pain

Chronic Neck Pain Clinical Trial

Official title:

Does The Use Of Analgesic Current Therapies Increase The Effectiveness Of Neck Stabilization Exercises For Improving Pain, Disability, Mood, And Quality Of Life In Chronic Neck Pain? A Randomized, Controlled, Single-Blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03121859
• Other study ID #: 2017-SHHY
• Status: Completed
• Phase: N/A
• First received: April 10, 2017
• Last updated: April 19, 2017
• Start date: October 1, 2015
• Est. completion date: April 1, 2017

Study information

• Verified date: April 2017
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Does the use of analgesic current therapies increase the effectiveness of neck stabilization exercises for improving pain, disability, mood, and quality of life in chronic neck pain? a randomized, controlled, single-blind study

Description:

Analgesic therapies; such as interferential current (IFC) and transcutaneous electrical nerve stimulation (TENS) have been applied solo or combined with exercise for management of neck pain (NP), however, the efficacy of these combinations are unclear. In this study, our objective were to determine if TENS or IFC increase the effectiveness of neck stabilization exercises on pain, disability, mood, and quality of life for chronic NP. 81 patients with chronic NP were included in the study. Patients were randomly assigned into 3 groups; Group I: neck stabilization exercise, Group II: TENS+ neck stabilization exercise and Group III: IFC+ neck stabilization exercise. Patients' pain levels (visual analogue scale (VAS)), quality of life (short form- 36), mood (Beck depression inventory (BDI)), levels of disability (Neck Pain and Disability Index) and the need for analgesics were evaluated prior to treatment, at 6th and 12th week follow-up. All participants had group exercise accompanied by a physiotherapist for 3 weeks and an additional 3 weeks of home exercise program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: April 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Both genders between 20-50 years, had chronic neck pain

Exclusion Criteria: Having disc hernia that causes neurological deficit

• Having malignity,

• Having neck pain secondary neurological or vascular disease.

• Pregnancy

• Having psychiatric disease

• Having arthritic disease

• Having any contraindication for electrotherapy

Related Conditions & MeSH terms

• Chronic Neck Pain
• Neck Pain

Intervention

Other:
• Neck stabilization exercise
Exercise
• TENS
Transcutaneous electrical nerve stimulation (TENS)
• IFC
Interferential current therapy(IFC)

Locations

Country	Name	City	State
Turkey	Hilal Yesil	Afyon	Eyalet/Yerleske

Sponsors (1)

Lead Sponsor	Collaborator
Hilal Yesil

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline VAS (Visual analog scale) at 6th and 12th weeks	The patients were asked to make an assessment of their pain between 0 (no pain) and 10 (severe pain).	Up to12 weeks
Secondary	Change from baseline quality of life (short form- 36) at 6th and 12th weeks	This is a self-administered scale, which is widely used to measure the quality of life. It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases. SF-36 includes 36 items and surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health.	Up to 12 weeks
Secondary	Change from baseline Beck depression inventory (BDI) at 6th and 12th weeks	The Beck Depression Inventory (BDI); was used to assess the depression levels of the patients. The BDI evaluates 21 symptoms of depression. These symptoms deal with emotions, behavioral changes, and somatic symptoms. Each symptom is rated on a 4-point intensity scale. Higher scores indicate more severe depression	Up to 12 weeks
Secondary	Change from baseline Neck Pain and Disability Index at 6th and 12th weeks	The questionnaire consists of 20 items and measures neck movements, pain intensity, effect of neck pain on emotion factors, and interference with daily life activities. Each section is scored on a 0-5 rating scale and total score ranges from 0 to 100.	Up to 12 weeks